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This rule will update FDA's existing National Environmental Policy Act (NEPA) regulations under 21 CFR part 25, Environmental Impact Considerations. The updates include removal of references to, and reliance upon, Council on Environmental Quality (CEQ) regulations 21 CFR parts 1500 through 1508; per Executive Order 14154, removal of FDA’s NEPA regulation on environmental effects abroad of major agency actions, 21 CFR 25.60; incorporation of statutory deadlines and page limits for streamlined reviews as mandated in the Fiscal Responsibility Act of 2023 (Public Law 1185); new and updated categorical exclusions that specify classes of actions that ordinarily do not require the preparation of an environmental assessment or environmental impact statement; and new and amended definitions and other conforming changes as warranted to improve clarity and prevent confusion. FDA is taking this action in response to Executive Order 14154, Unleashing American Energy, and the subsequent guidance issued on February 19, 2025, by CEQ entitled "Implementation of NEPA."

Overall Description of Deadline: Executive Order 14154 directed CEQ to provide guidance to agencies on implementing NEPA and to propose rescinding CEQ's NEPA regulations found at 40 CFR 1500 et seq.